A Study Comparing Laser Therapy With and Without a New Jaw Joint Locating Device in Skeletal Class II Patients Receiving Functional Orthodontic Treatment

Assessing the clinical accuracy of low level Lesar therapy in skeletal calss II patents undergoing myofunctional appliance therapy with-versus without extraoral condyle locating device and further evaluating the comparative clinical efficacy of said two therapy approaches: a randomised controlled trial - nill

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/102982

Enrollment

Registered

2026-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Phase I EOCLD Validation time required 30 days Phase IIEOCLD Guided LLLT with Myofunctional Appliance time required 8 months : Participants will undergo condylar localization using th

Eligibility

Inclusion criteria

Inclusion criteria: Age group: 10 35 years No prior orthodontic or orthopedic treatment Normal TMJ function and absence of pain or clicking

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients with craniofacial syndromes, cleft lip/palate, or any congenital facial deformities. History of previous orthodontic or orthopedic treatment. Presence of systemic diseases (e.g., growth hormone disorders, juvenile arthritis) affecting growth. Temporomandibular joint (TMJ) disorders, pain, or restricted mouth opening at baseline Patients with poor oral hygiene, active dental caries, or periodontal disease. Uncooperative behaviour or inability to follow study protocols. Contraindications to LLLT, such as photosensitivity, epilepsy, or ongoing medication affecting bone metabolism. Inability or refusal to undergo CBCT imaging. Patients with metal allergies or hypersensitivity to appliance materials

Design outcomes

Primary

Measure	Time frame
phase 1-Accuracy (mm deviation) of EOCLD vs radiographic condyle location phase 2-Condylar growth changes ( position, dimension)Timepoint: phase 1-Accuracy (mm deviation) of EOCLD vs radiographic condyle location 30 days for pilot study phase 2-Condylar growth changes ( position, dimension) 8 months after appliance delivary	—

Secondary

Measure	Time frame
Phase 1-ICC intra-/inter-operator reliability, repeatability, time efficiency, operator feedback Phase 2-Skeletal changes (ANB, mandibular length), functional outcomes, soft tissue changes, treatment duration, discomfort, compliance, adverse effectsTimepoint:	—

Countries

India

Contacts

Public ContactDR SHILPA M KENDRE

Sharad Pawar Dental College and Hospital Sawangi Wardha

pallavi.ortho@dmiher.edu.in9923355361

Outcome results